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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 217197

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NDA 217197 describes ACETAZOLAMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Cadila, Heritage Pharma, Indicus Pharma, Micro Labs Ltd India, Nostrum Labs Inc, Novast Labs, Rising, Ajanta Pharma Ltd, Alra, Appco, Ascot, Breckenridge, Chartwell Molecular, Epic Pharma Llc, Hibrow Hlthcare, Mankind Pharma, Ne Rx Pharma, Novitium Pharma, Rubicon, Strides Pharma, Sun Pharm Industries, Taro, Torrent, Vangard, Watson Labs, Zydus Lifesciences, Avet Lifesciences, Endo Operations, Hikma, Hospira, Mylan Asi, Xgen Pharms, and Zydus Pharms, and is included in thirty-seven NDAs. It is available from thirty-three suppliers. Additional details are available on the ACETAZOLAMIDE profile page.

The generic ingredient in ACETAZOLAMIDE is acetazolamide sodium. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.

Summary for 217197

Tradename:	ACETAZOLAMIDE
Applicant:	Ne Rx Pharma
Ingredient:	acetazolamide
Patents:	0

Pharmacology for NDA: 217197

Mechanism of Action	Carbonic Anhydrase Inhibitors

Medical Subject Heading (MeSH) Categories for 217197

Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics

Suppliers and Packaging for NDA: 217197

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	217197	ANDA	Aarkish Pharmaceuticals NJ Inc.	81005-104	81005-104-01	100 TABLET in 1 BOTTLE (81005-104-01)
ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	217197	ANDA	Aarkish Pharmaceuticals NJ Inc.	81005-104	81005-104-10	1000 TABLET in 1 BOTTLE (81005-104-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	May 9, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	May 9, 2023	TE:	AB	RLD:	No

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